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NIH Launches Human Safety Study of Ebola Vaccine Candidate

August 29, 2014

The National Institute of Allergy and Infectious Diseases will begin the first in a series of trials for an Ebola vaccine during the week of Sept. 1.

ISPE Previews Drug Shortages Prevention Plan

August 28, 2014

ISPE released an advance look at the Introductory Summary of its Drug Shortages Prevention Plan.

FDA Issues Warning Letter to India's Marck Biosciences

August 20, 2014

FDA found violations of cGMP at finished-drug manufacturer in India.

FDA Warns about Fraudulent Ebola Treatments

August 15, 2014

Consumers warned about products claiming to prevent or treat the Ebola virus.

Report Predicts Generics Production Return to US

August 15, 2014

Concerns about quality in overseas production may bring generic drug production back to the United States, concludes CPhI study.

EMA Invites Comments on New Guidance for Vaccine Development

August 4, 2014

EMA has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication of a module on the quality requirements.

FDA Issues Warning Letter to Italian API Manufacturer

July 16, 2014
PTSM: Pharmaceutical Technology Sourcing and Management

Trifarma cited for significant deviations in data collection and security, and employee training.

Hospira Acquires Orchid's API Manufacturing and R&D Facilities

July 9, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

Hospira acquires assets from Orchid Chemicals & Pharmaceuticals for $218 million.

BMS Recalls Coumadin Vials Due to Particulate Matter

July 1, 2014

Bristol-Myers Squibb issues a voluntary US recall of Coumadin (warfarin sodium) for injection due to presence of particulate matter.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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